David M. Smith
11-10-2008, 03:30 PM
Date Recall Initiated July 10, 2007
Date Posted January 09, 2008
Recall Number Z-0297-2008
Product Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039
Code Information Serial numbers : 114792, 114819, 114822, 114827, 114829, 114839, 114843, 114844, 114845, 114846, 114847, 114848, 114849, 114851, 114859, 114860, 114861, 114863, 114864, 114871, 117874, 114876, 114880, 114881, 114882, 114885, 114890, 114891, 114894, 114895, 114909, 114910, 114912, 114918, 114921, 114927, 114928, 114930, 114931, 114935, 114941, 114944, 114947, 114948, 114949, 114953, 114957, 114958, 114959, 114960, 114962, 114963, 114971, 114977, 114978, 114730, 114735, 114745, 114761, 114781, 114785, 114826, 114865, 114868, 114869, 114896, 114936, 5000, 5001, 112919, 112925, 112971, 112980, 112981, 112984, 112989, 112992, 113005, 113009, 113013, 113015, 113037, 113040, 113041, 113042, 113045, 113048, 113051, 113052, 113053, 113055, 113058, 113061, 113067, 113068, 113075, 113076, 113079, 113080, 113101, 113102, 113105, 113143, 113145, 113147, 113204, 113225, 113257, 113259, 113302, 113407, 113411, 113414, 113462, 113469, 113566, 113682, 113706, 113715, 113759, 113767, 113803, 113825, 113826, 113827, 113828, 113829, 113831, 113832, 113834, 113835, 113841, 113843, 113846, 113847, 113848, 113849, 113850, 113851, 113852, 113856, 113863, 113873, 113900, 113917, 113921, 113945, 113947, 113950, 113957, 113980, 113986, 114014, 114043, 114052, 114061, 114164, 114172, 114176, 114186, 114233, 114254, 114255, 114271, 114274, 114313, 114351, 114356, 114363, 114406, 114461, 114474, 114475, 114481, 114482, 114493, 114536, 114573, 114583, 114584, 114590, 114596, 114587, 114602, 114612, 114614, 114616, 114617, 114621, 114640, 114644, 114647, 114652, 114655, 114661, 114665, 114669, 114671, 114675, 114687, 114690, 114694, 114699, 114703, 114706, 114716, 114721, 114728, 114734, 114732, 114740, 114742, 114743, 114744, 114749, 114751, 114753, 114754, 114755, 114757, 114759, 114760, 114762, 114764, 114768, 114770, 114771, 114773, 114775, 114777, 114782, 114789, 114790, 114791, 114792, 114793, 114794, 114796, 114799, 114802, 114805, 114807, 114808, 114809, 114810, 114811, 114813, 114818, 114819, 114820, 114821, 114822, 114825, 114827, 114828, 114829, 114831, 114833, 114834, 114835, 114836, 114838, 114842, 114843, 114844, 114844, 114845, 114846, 114847, 114848, 114849, 114850, 114851, 114853, 114857, 114859, 114860, 114861, 114863, 114864, 114866, 114870, 114873, 114878, 114886, 114899, 114901, 114908, 114914, 114916, 114920, 114926, 114937, 114939, 114940, 114943, 114945, 114950, 114955, 114973, 113322, 113904, 114228, 114415, 114524, 114528, 114566, 114568, 114623, 114630, 114632, 114635, 114636, 114645, 114646, 114651, 114672, 114685, 114717, 114723, 114724, 114725, 114726, 114727, 114729, 114733, 114736, 114737, 114739, 114741, 114746, 114747, 114748, 114750, 114752, 114758, 114769, 114765, 114766, 114767, 114779, 114780, 114783, 114784, 114786, 114788, 114795, 114797, 114798, 114800, 114801, 114803, 114804, 114806, 114812, 114814, 114816, 114823, 114824, 114830, 114832, 114837, 114840, 114841, 114852, 114854, 114855, 114858, 114862, 114867, 114868, 114869, 114872, 114875, 114877, 114879, 114887, 114888, 114889, 114892, 114893, 114897, 114898, 114900, 114902, 114903, 114904, 114905, 114907, 114911, 114913, 114915, 114919, 114922, 114923, 114924, 114925, 114929, 114933, 113249001, 113344001, 113458001, 113593001, 113731001, 113887001, and 113159001
Recalling Firm/Manufacturer Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View , California 94043
Reason For Recall Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.
Action The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.
Quantity in Commerce 418 units (Z-0297-0298-2008)
Distribution Worldwide: Product was distributed to medical facilities
Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD, and IN, and internationally to Canada, Germany, Australia, Sweden, Saudi Arabia, Chile, South Korea, Mexico, France, UK, Taiwan, Singapore, Denmark, Brazil, New Zealand, Ireland, Belgium, Norway, Serbia, Vietnam, UK, Poland, China, Spain, South Africa, Austria, Croatia, Russia, Greece, Trinidad and Tobago, United Arab Emirates, India, Japan, Malaysia, Turkey, Thailand, Norway, Slovakia, Romania, Netherlands, Switzerland, Portugal, Italy, and Venezuela.
Date Posted January 09, 2008
Recall Number Z-0297-2008
Product Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039
Code Information Serial numbers : 114792, 114819, 114822, 114827, 114829, 114839, 114843, 114844, 114845, 114846, 114847, 114848, 114849, 114851, 114859, 114860, 114861, 114863, 114864, 114871, 117874, 114876, 114880, 114881, 114882, 114885, 114890, 114891, 114894, 114895, 114909, 114910, 114912, 114918, 114921, 114927, 114928, 114930, 114931, 114935, 114941, 114944, 114947, 114948, 114949, 114953, 114957, 114958, 114959, 114960, 114962, 114963, 114971, 114977, 114978, 114730, 114735, 114745, 114761, 114781, 114785, 114826, 114865, 114868, 114869, 114896, 114936, 5000, 5001, 112919, 112925, 112971, 112980, 112981, 112984, 112989, 112992, 113005, 113009, 113013, 113015, 113037, 113040, 113041, 113042, 113045, 113048, 113051, 113052, 113053, 113055, 113058, 113061, 113067, 113068, 113075, 113076, 113079, 113080, 113101, 113102, 113105, 113143, 113145, 113147, 113204, 113225, 113257, 113259, 113302, 113407, 113411, 113414, 113462, 113469, 113566, 113682, 113706, 113715, 113759, 113767, 113803, 113825, 113826, 113827, 113828, 113829, 113831, 113832, 113834, 113835, 113841, 113843, 113846, 113847, 113848, 113849, 113850, 113851, 113852, 113856, 113863, 113873, 113900, 113917, 113921, 113945, 113947, 113950, 113957, 113980, 113986, 114014, 114043, 114052, 114061, 114164, 114172, 114176, 114186, 114233, 114254, 114255, 114271, 114274, 114313, 114351, 114356, 114363, 114406, 114461, 114474, 114475, 114481, 114482, 114493, 114536, 114573, 114583, 114584, 114590, 114596, 114587, 114602, 114612, 114614, 114616, 114617, 114621, 114640, 114644, 114647, 114652, 114655, 114661, 114665, 114669, 114671, 114675, 114687, 114690, 114694, 114699, 114703, 114706, 114716, 114721, 114728, 114734, 114732, 114740, 114742, 114743, 114744, 114749, 114751, 114753, 114754, 114755, 114757, 114759, 114760, 114762, 114764, 114768, 114770, 114771, 114773, 114775, 114777, 114782, 114789, 114790, 114791, 114792, 114793, 114794, 114796, 114799, 114802, 114805, 114807, 114808, 114809, 114810, 114811, 114813, 114818, 114819, 114820, 114821, 114822, 114825, 114827, 114828, 114829, 114831, 114833, 114834, 114835, 114836, 114838, 114842, 114843, 114844, 114844, 114845, 114846, 114847, 114848, 114849, 114850, 114851, 114853, 114857, 114859, 114860, 114861, 114863, 114864, 114866, 114870, 114873, 114878, 114886, 114899, 114901, 114908, 114914, 114916, 114920, 114926, 114937, 114939, 114940, 114943, 114945, 114950, 114955, 114973, 113322, 113904, 114228, 114415, 114524, 114528, 114566, 114568, 114623, 114630, 114632, 114635, 114636, 114645, 114646, 114651, 114672, 114685, 114717, 114723, 114724, 114725, 114726, 114727, 114729, 114733, 114736, 114737, 114739, 114741, 114746, 114747, 114748, 114750, 114752, 114758, 114769, 114765, 114766, 114767, 114779, 114780, 114783, 114784, 114786, 114788, 114795, 114797, 114798, 114800, 114801, 114803, 114804, 114806, 114812, 114814, 114816, 114823, 114824, 114830, 114832, 114837, 114840, 114841, 114852, 114854, 114855, 114858, 114862, 114867, 114868, 114869, 114872, 114875, 114877, 114879, 114887, 114888, 114889, 114892, 114893, 114897, 114898, 114900, 114902, 114903, 114904, 114905, 114907, 114911, 114913, 114915, 114919, 114922, 114923, 114924, 114925, 114929, 114933, 113249001, 113344001, 113458001, 113593001, 113731001, 113887001, and 113159001
Recalling Firm/Manufacturer Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View , California 94043
Reason For Recall Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.
Action The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.
Quantity in Commerce 418 units (Z-0297-0298-2008)
Distribution Worldwide: Product was distributed to medical facilities
Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD, and IN, and internationally to Canada, Germany, Australia, Sweden, Saudi Arabia, Chile, South Korea, Mexico, France, UK, Taiwan, Singapore, Denmark, Brazil, New Zealand, Ireland, Belgium, Norway, Serbia, Vietnam, UK, Poland, China, Spain, South Africa, Austria, Croatia, Russia, Greece, Trinidad and Tobago, United Arab Emirates, India, Japan, Malaysia, Turkey, Thailand, Norway, Slovakia, Romania, Netherlands, Switzerland, Portugal, Italy, and Venezuela.